MS-DETECT: Early Detection of Multiple Sclerosis Progression with MSCopilot® Detect

Ad scientiam

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Device: MSCopilot® Detect mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT05816122

MS-DETECT

Details and patient eligibility

About

The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS).

The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution.

A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients.

Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL).

Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression.

The study will include 314 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

Enrollment: 314 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients living with RRMS or SPMS, aged 30 to 65
• EDSS score between 2.5 to 6.5 points
• With a disease duration > 5 years
• Clinically stable during the last 3 months before inclusion (no relapses, no disability progression)
• No change in the DMT* during the last 3 months before inclusion
• Receiving optimal symptomatic treatments at baseline (clinician's judgment)
• Owns a personal smartphone which mobile operating system is above 14 for IOS (iPhone) and 8 for Android included with a good internet connexion
• Able to use a smartphone
• Able to read language in wich the mobile application is available and able to understand pictograms.
• Applicable to patients enrolled in France only: affiliated to a social security system.

Exclusion criteria

• Medically unstable conditions that may hinder patient's ability to comply with the study procedures
• Inability to use a smartphone or MSCopilot® Detect application
• Patient with corrected visual acuity less than 4/10 (Monoyer) or 20/50 (Snellen at 20 feet) or +0,4 (LogMAR)
• Pregnancy and nursing women
• Persons under guardianship or curatorship
• Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
• Patients have participated in another clinical study within the previous 30 days of screening or are currently participating in another study that, in the opinion of the Investigator, might interfere with the patient's full participation in the study or confound the assessment of the patient or outcome of the study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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314 participants in 1 patient group

MSCopilot® Detect

Experimental group

Description:

Performance of digital tests and standard test in clinic at D0, M6, M12, M18 and M24 (if applicable) Use of MSCopilot® Detect at-home in between visits during 18 or 24 months (if applicable)

Treatment:

Device: MSCopilot® Detect mobile application